Catalog Number

-

Brand Name

Focal Guide 10 x 10

Version/Model Number

5520-2024

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

2290a9ff-8c51-4cf4-8734-d7c5b91372d8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

10841494100596

Quantity per Package

5

Contains DI Package

00841494100599

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-